Stress Balls for Anxiety During Thyroid Biopsies
Recruiting in Palo Alto (17 mi)
RJ
Overseen byRobert J Abraham, MD, FRCPC
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Nova Scotia Health Authority
Disqualifiers: Previous biopsy, Multiple lesions, Allergy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
Patients undergoing thyroid biopsy under local anesthetic will be asked to fill out a questionnaire that evaluates their anxiety level before and after their procedure. Patients will be randomly assigned to either use an anxiety reducing tool (stress balls in each hand) to take their mind off the procedure or will not receive an anxiety reducing tool.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Stress Balls for reducing anxiety during thyroid biopsies?
Is using a stress ball safe for humans?
How does using stress balls for anxiety during thyroid biopsies differ from other treatments for anxiety?
Research Team
RJ
Robert J Abraham, MD, FRCPC
Principal Investigator
Nova Scotia Health Authority/Dalhousie University
Eligibility Criteria
This trial is for adults aged 18 or older who are about to undergo a thyroid biopsy under local anesthetic and can consent to treatment and research. It's designed for those experiencing anxiety related to the procedure.Inclusion Criteria
I am 18 years old or older.
I am having a thyroid or prostate biopsy under local anesthetic and can consent to treatment and research.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Procedure
Participants undergo thyroid biopsy with or without the use of stress balls to assess anxiety levels
Approximately 2 hours
1 visit (in-person)
Follow-up
Participants complete post-procedure questionnaires to assess intraprocedural anxiety
Immediate post-procedure
1 visit (in-person)
Data Analysis
Data collected from questionnaires is analyzed to determine the efficacy of stress balls in reducing anxiety
1 year
Treatment Details
Interventions
- Stress Balls (Behavioural Intervention)
Trial OverviewThe study is testing whether using stress balls during a thyroid biopsy can help reduce anxiety. Participants will be randomly divided into two groups: one will use stress balls, while the other won't receive any anxiety-reducing tools.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Stress BallsExperimental Treatment1 Intervention
Patients given a stress ball in each hand.
Group II: No Stress BallsActive Control1 Intervention
Patients NOT given a stress ball in each hand.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Nova Scotia HealthHalifax, Canada
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Who Is Running the Clinical Trial?
Nova Scotia Health Authority
Lead Sponsor
Trials
302
Patients Recruited
95,300+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effect of an Information Video before Thyroid Biopsy on Patients' Anxiety.Ay, S., Ata, N., Oncu, F.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate.Chiu, LP., Tung, HH., Lin, KC., et al.[2020]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Imaging-Guided Core-Needle Breast Biopsy: Impact of Meditation and Music Interventions on Patient Anxiety, Pain, and Fatigue.Soo, MS., Jarosz, JA., Wren, AA., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Anxiety in patients with symptomatic breast disease: effects of immediate versus delayed communication of results.Ubhi, SS., Shaw, P., Wright, S., et al.[2022]
In a study of 82 patients undergoing their first thyroid fine-needle aspiration biopsy (TFNAB), listening to classical music significantly reduced anxiety levels during the procedure, as measured by the State Anxiety Inventory (SAI).
However, the music intervention did not have a significant effect on pain perception, as indicated by the visual analog scale (VAS), suggesting that while music can help with anxiety, it may not alleviate pain during medical procedures.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The impact of classical music on anxiety and pain perception during a thyroid fine needle aspiration biopsy.Barlas, T., Sodan, HN., Avci, S., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial.Karatas, TC., Gezginci, E.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Türkiye.Apaydin Cirik, V., Türkmen, AS., Ayaz, M.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effect of active and passive distraction techniques while administering local anaesthesia on the dental anxiety, behaviour and pain levels of children: a randomised controlled trial.Shekhar, S., Suprabha, BS., Shenoy, R., et al.[2022]
An 8-week stress management intervention significantly reduced anti-thyroglobulin (anti-TG) antibody levels in women with Hashimoto's thyroiditis, suggesting a potential benefit in managing autoimmune thyroid conditions.
Participants in the stress management group also experienced notable improvements in stress, depression, anxiety levels, and overall lifestyle, indicating that stress management can positively impact both mental health and thyroid function.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Stress Management in Women with Hashimoto's thyroiditis: A Randomized Controlled Trial.Markomanolaki, ZS., Tigani, X., Siamatras, T., et al.[2022]
In a study of 30 adolescents aged 10 to 16 with type 1 diabetes, the use of primary control coping strategies, like problem solving and emotional expression, was linked to better quality of life, higher competence, and improved metabolic control.
Conversely, disengagement coping strategies, such as withdrawal or denial, were associated with lower competence and poorer metabolic control, highlighting the importance of adaptive coping strategies in managing diabetes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Coping and resilience in adolescents with type 1 diabetes.Jaser, SS., White, LE.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
The effects of anxiety management training on the control of juvenile diabetes mellitus.Rose, MI., Firestone, P., Heick, HM., et al.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A case control study on psychiatric disorders in Hashimoto disease and Euthyroid Goitre: not only depressive but also anxiety disorders are associated with thyroid autoimmunity.Carta, MG., Hardoy, MC., Carpiniello, B., et al.[2020]
Adults with Type 1 diabetes (T1D) experience a relentless burden from continuous self-management tasks, which significantly affect their coping experiences.
Utilizing technology, expert-led online support, and peer support can help ease the challenges of living with T1D, suggesting these resources should be prioritized in interventions.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
"No-one realises what we go through as Type 1s": A qualitative photo-elicitation study on coping with diabetes.Nettleton, JA., Burton, AE., Povey, RC.[2022]
References
Effect of an Information Video before Thyroid Biopsy on Patients' Anxiety. [2022]
Effectiveness of stress management in patients undergoing transrectal ultrasound-guided biopsy of the prostate. [2020]
Imaging-Guided Core-Needle Breast Biopsy: Impact of Meditation and Music Interventions on Patient Anxiety, Pain, and Fatigue. [2022]
Anxiety in patients with symptomatic breast disease: effects of immediate versus delayed communication of results. [2022]
The impact of classical music on anxiety and pain perception during a thyroid fine needle aspiration biopsy. [2023]
The Effect of Using a Stress Ball During Endoscopy on Pain, Anxiety, and Satisfaction: A Randomized Controlled Trial. [2023]
Effectiveness of stress ball and relaxation exercises on polymerase chain reaction (RRT-PCR) test-induced fear and pain in adolescents in Türkiye. [2023]
Effect of active and passive distraction techniques while administering local anaesthesia on the dental anxiety, behaviour and pain levels of children: a randomised controlled trial. [2022]
Stress Management in Women with Hashimoto's thyroiditis: A Randomized Controlled Trial. [2022]
Coping and resilience in adolescents with type 1 diabetes. [2022]
The effects of anxiety management training on the control of juvenile diabetes mellitus. [2019]
A case control study on psychiatric disorders in Hashimoto disease and Euthyroid Goitre: not only depressive but also anxiety disorders are associated with thyroid autoimmunity. [2020]
"No-one realises what we go through as Type 1s": A qualitative photo-elicitation study on coping with diabetes. [2022]